Device product
TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
Z-0342-2014
Product summary
- Event
- Event 66688
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 components
- Official record key
device-enforcement:Z-0342-2014
Official wording
Reason: The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Code information: Item no. 1739993, All serial numbers.
Distribution pattern: US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
Derived failure modes
-
Unknown
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.